File No: LTD/1777
September 2014
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
2-Pyrrolidinone, 1-ethenyl-, polymer with 1-ethenyl-1H-imidazole
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification
and Assessment) Act 1989 (the Act) and Regulations. This legislation is an Act of the Commonwealth of
Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered
by the Department of Health, and conducts the risk assessment for public health and occupational health and
safety. The assessment of environmental risk is conducted by the Department of the Environment.
For the purposes of subsection 78(1) of the Act, this Public Report may be inspected at our NICNAS office by
appointment only at Level 7, 260 Elizabeth Street, Surry Hills NSW 2010.
This Public Report is also available for viewing and downloading from the NICNAS website or available on
request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS
Administration Coordinator at:
Street Address:
Postal Address:
TEL:
FAX:
Website:
Director
NICNAS
Level 7, 260 Elizabeth Street, SURRY HILLS NSW 2010, AUSTRALIA.
GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
+ 61 2 8577 8800
+ 61 2 8577 8888
www.nicnas.gov.au
TABLE OF CONTENTS
SUMMARY ............................................................................................................................................................ 3
CONCLUSIONS AND REGULATORY OBLIGATIONS ................................................................................... 3
ASSESSMENT DETAILS ..................................................................................................................................... 6
1.
APPLICANT AND NOTIFICATION DETAILS .................................................................................... 6
2.
IDENTITY OF CHEMICAL .................................................................................................................... 6
3.
ANALOGUE DATA ................................................................................................................................ 7
4.
COMPOSITION ....................................................................................................................................... 7
5.
PHYSICAL AND CHEMICAL PROPERTIES ....................................................................................... 7
6.
INTRODUCTION AND USE INFORMATION ..................................................................................... 8
7.
HUMAN HEALTH IMPLICATIONS ..................................................................................................... 9
7.1.
Exposure Assessment ...................................................................................................................... 9
7.1.1. Occupational Exposure ............................................................................................................... 9
7.1.2. Public Exposure .......................................................................................................................... 9
7.2.
Human Health Effects Assessment ............................................................................................... 10
7.3.
Human Health Risk Characterisation ............................................................................................ 10
7.3.1. Occupational Health and Safety ............................................................................................... 10
7.3.2. Public Health ............................................................................................................................ 10
8.
ENVIRONMENTAL IMPLICATIONS ................................................................................................. 11
8.1.
Environmental Exposure & Fate Assessment ............................................................................... 11
8.1.1. Environmental Exposure .......................................................................................................... 11
8.1.2. Environmental Fate .................................................................................................................. 11
8.1.3. Predicted Environmental Concentration (PEC) ........................................................................ 11
8.2.
Environmental Effects Assessment ............................................................................................... 12
8.2.1. Predicted No-Effect Concentration .......................................................................................... 12
8.3.
Environmental Risk Assessment ................................................................................................... 12
APPENDIX A: PHYSICAL AND CHEMICAL PROPERTIES ........................................................................................... 13
APPENDIX B: TOXICOLOGICAL INVESTIGATIONS ................................................................................................... 14
B.1.
Acute toxicity – oral ...................................................................................................................... 14
B.2.
Irritation – skin .............................................................................................................................. 14
B.3.
Genotoxicity – bacteria ................................................................................................................. 15
APPENDIX C: ENVIRONMENTAL FATE AND ECOTOXICOLOGICAL INVESTIGATIONS ............................................... 16
C.1.
Environmental Fate ....................................................................................................................... 16
C.1.1. Ready biodegradability ............................................................................................................. 16
C.2.
Ecotoxicological Investigations .................................................................................................... 16
C.2.1. Acute toxicity to fish ................................................................................................................ 16
C.2.2. Acute toxicity to aquatic invertebrates ..................................................................................... 17
C.2.3. Algal growth inhibition test ...................................................................................................... 18
BIBLIOGRAPHY ................................................................................................................................................. 19
September 2014
NICNAS
SUMMARY
The following details will be published in the NICNAS Chemical Gazette:
ASSESSMENT
APPLICANT(S)
CHEMICAL OR
HAZARDOUS
INTRODUCTION
TRADE NAME
CHEMICAL
VOLUME
2-Pyrrolidinone, 1ethenyl-, polymer
with 1-ethenyl-1Himidazole
Yes
≤ 20 tonnes per
annum
REFERENCE
LTD/1777
BASF Australia
Ltd
USE
Component of laundry
detergent
CONCLUSIONS AND REGULATORY OBLIGATIONS
Hazard classification
Based on the available information, the notified polymer is recommended for hazard classification according to
the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for
industrial chemicals in Australia. The recommended hazard classification is presented in the table below.
Hazard classification
Hazard statement
Skin Irritation – Category 2
H315 – Causes skin irritation
Based on the available information, the notified polymer is recommended for hazard classification according to
the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004) with the following risk phrase:
R38: Irritating to skin.
Human health risk assessment
Under the conditions of the occupational settings described, the notified polymer is not considered to pose an
unreasonable risk to the health of workers.
When used in the proposed manner, the notified polymer is not considered to pose an unreasonable risk to
public health.
Environmental risk assessment
On the basis of the PEC/PNEC ratio and the assessed use pattern, the notified polymer is not considered to pose
an unreasonable risk to the environment.
Recommendations
REGULATORY CONTROLS
Hazard Classification and Labelling

The notified polymer should be classified as follows:
 Skin Irritation (Category 2): H315 – Causes skin irritation
The above should be used for products/mixtures containing the notified chemical, if applicable, based on the
concentration of the notified chemical present and the intended use/exposure scenario.
CONTROL MEASURES
Occupational Health and Safety

A person conducting a business or undertaking at a workplace should implement the following
engineering controls to minimise occupational exposure to the notified polymer during reformulation:
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September 2014

NICNAS
use of enclosed, automated processes, where possible

A person conducting a business or undertaking at a workplace should implement the following safe
work practices to minimise occupational exposure during handling of the notified polymer:
 avoid contact with skin

A person conducting a business or undertaking at a workplace should ensure that the following personal
protective equipment is used by workers to minimise occupational exposure to the notified polymer:
 Impervious gloves
 Goggles
 Protective clothing
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.

A copy of the (M)SDS should be easily accessible to employees.

If products and mixtures containing the notified polymer are classified as hazardous to health in
accordance with the Globally Harmonised System for the Classification and Labelling of Chemicals
(GHS) as adopted for industrial chemicals in Australia, workplace practices and control procedures
consistent with provisions of State and Territory hazardous substances legislation should be in
operation.
Disposal

Where reuse or recycling are not available or practical, dispose of the polymer in an environmentally
sound manner in accordance with relevant Commonwealth, state, territory and local government
legislation
Emergency procedures

Spills or accidental release of the notified polymer should be handled by physical containment,
collection and subsequent safe disposal.
Regulatory Obligations
Secondary Notification
This risk assessment is based on the information available at the time of notification. The Director may call for
the reassessment of the chemical under secondary notification provisions based on changes in certain
circumstances. Under Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989) the
notifier, as well as any other importer or manufacturer of the notified chemical, have post-assessment regulatory
obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the
notified polymer is listed on the Australian Inventory of Chemical Substances (AICS).
Therefore, the Director of NICNAS must be notified in writing within 28 days by the notifier, other importer or
manufacturer:
(1)
Under Section 64(2) of the Act; if
 the function or use of the polymer has changed from use as a component of laundry detergent, or is
likely to change significantly;
 the amount of polymer being introduced has increased, or is likely to increase, significantly;
 the polymer has begun to be manufactured in Australia;
 additional information has become available to the person as to an adverse effect of the polymer on
occupational health and safety, public health, or the environment.
The Director will then decide whether a reassessment (i.e. a secondary notification and assessment) is required.
No additional secondary notification conditions are stipulated.
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September 2014
NICNAS
(Material) Safety Data Sheet
The (M)SDS of the notified polymer provided by the notifier was reviewed by NICNAS. The accuracy of the
information on the (M)SDS remains the responsibility of the applicant.
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NICNAS
ASSESSMENT DETAILS
1.
APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
BASF Australia Ltd (ABN: 62 008 437 867)
Level 12, 28 Freshwater Place
SOUTHBANK VIC 3006
NOTIFICATION CATEGORY
Limited: Synthetic polymer with Mn  1,000 Da.
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
Data items and details claimed exempt from publication: molecular weight, analytical data, degree of purity,
polymer constituents, residual monomers, impurities, additives/adjuvants and import volume.
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
No variation to the schedule of data requirements is claimed.
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
None
NOTIFICATION IN OTHER COUNTRIES
Canada (2014), China (2013), EU (2007), Japan (2014), Korea (2011), New Zealand (2012), Philippines (2011)
and USA (2002)
2.
IDENTITY OF CHEMICAL
MARKETING NAME(S)
Sokalan® HP 56 K
Sokalan® HP 56 Granules
CAS NUMBER
29297-55-0
CHEMICAL NAME
2-Pyrrolidinone, 1-ethenyl-, polymer with 1-ethenyl-1H-imidazole
OTHER NAME(S)
Vinylpyrrolidone – vinylimidazole copolymer
MOLECULAR FORMULA
(C6H9NO.C5H6N2)x
STRUCTURAL FORMULA
MOLECULAR WEIGHT
Number Average Molecular Weight (Mn) > 10,000 Da
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September 2014
NICNAS
ANALYTICAL DATA
Reference IR and GPC data were provided.
3. ANALOGUE DATA
Toxicological data was provided for the human health and environmental effects on a version of the notified
chemical which was produced via a different manufacturing process with a significantly lower molecular weight
(although still > 1,000 Da) than the notified polymer as proposed for introduction into Australia.
4.
COMPOSITION
DEGREE OF PURITY
> 99%
LOSS OF MONOMERS, OTHER REACTANTS, ADDITIVES, IMPURITIES
The notified polymer is stable under standard operating conditions and no loss of monomers, reactants, additives
or impurities is expected.
DEGRADATION PRODUCTS
The notified polymer is not expected to degrade under normal conditions of use.
5.
PHYSICAL AND CHEMICAL PROPERTIES
APPEARANCE AT 20 ºC AND 101.3 kPa: white to yellow granules with product specific odour
Property
Melting Point/Freezing
Point
Boiling Point
Glass
transition
temperature
Density
Vapour Pressure
Value
130 °C
Data Source/Justification
(M)SDS
Not determined
176 °C
Expected to decompose prior to boiling
Measured
1,124 kg/m3 at 20 °C
< 1.3 x 10-9 kPa
Water Solubility
Hydrolysis as a Function
of pH
Partition Coefficient
(n-octanol/water)
Adsorption/Desorption
≥ 686 g/L at 23 °C
> 1 year at 25 °C
Measured
Estimated based on NAMW > 1,000 Da
(US EPA 2013)
Measured
Measured
log Pow < - 4.8.at 23 °C
Measured
Not determined
Dissociation Constant
Not determined
Particle Size
Inhalable fraction (< 100 m): 0%
Respirable fraction (< 10 m): 0%
> 100 °C at
> 200 °C
The notified polymer is expected to adsorb
to sediment sludge due to the high
molecular weight (> 1000 Da) and potential
cationic functional groups
The notified polymer contains basic
functional groups that have cationic
potential
Measured
Flash Point
Autoignition
Temperature
Explosive Properties
Oxidising Properties
Not determined
Not determined
(M)SDS
(M)SDS
Contains no functional groups that would
imply explosive properties
Contains no functional groups that would
imply oxidative properties
DISCUSSION OF PROPERTIES
For full details of tests on physical and chemical properties, refer to Appendix A.
Reactivity
The notified polymer is expected to be stable under normal conditions of use.
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September 2014
NICNAS
Physical hazard classification
Based on the submitted physico-chemical data depicted in the above table, the notified polymer is not
recommended for hazard classification according to the Globally Harmonised System for the Classification and
Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia.
6.
INTRODUCTION AND USE INFORMATION
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
The notified polymer will not be manufactured in Australia. The notified polymer will be imported into Australia
in pure form as granules (Sokalan® HP 56 Granules) or as a component of a liquid mixture (Sokalan® HP 56 K)
at a concentration of 30%. There is a possibility that the notified polymer will be imported at up to 0.5%
concentration in laundry powder detergents in the future.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year
Tonnes
1
≤ 20
2
≤ 20
3
≤ 20
4
≤ 20
5
≤ 20
PORT OF ENTRY
Melbourne and Sydney
TRANSPORTATION AND PACKAGING
The notified polymer in its pure form will be imported in 20 kg plastic bags and in the formulated form it will be
imported in 1,000 L intermediate bulk containers or 120 kg plastic drums. Within Australia the notified polymer
will be distributed by road.
USE
The notified polymer is a dye transfer inhibitor that will be used as a component of domestic laundry detergents
at up to 0.5% concentration.
OPERATION DESCRIPTION
Reformulation for liquid laundry detergent
Product containing the notified polymer will typically be transferred from the drum or intermediate bulk
container by inserting a dip pipe and pumping to a closed blending tank under local exhaust ventilation. After
blending into the liquid laundry detergent, the end-use product containing up to 0.5% of the notified polymer
will be transferred via automatic filling machines into appropriate containers for distribution to retail outlets.
Reformulation for powdered laundry detergents
Powdered laundry detergents will be made by a 3 step spray drying process – crutching, spray drying and post
addition. Crutching involves mixing detergent raw materials together in a blending vessel to form a thick slurry
(containing the notified polymer at up to 1%). The slurry will be transferred from the holding tank to the blend
vessel using dedicated pipework and then pumped as a stream of droplets into a spray drying tower and dried to
form hollow powder beads. The spray dried beads will then be mixed with small amounts of other dry
ingredients to produce laundry powders containing the notified polymer at up to 0.5% concentration. The
detergent will then be conveyed to the packaging area for distribution to retail outlets.
End-use
The laundry powder containing the notified polymer at a concentration of < 0.5% will be used to wash clothes in
washing machines and may also be used for hand-washing of clothes.
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September 2014
7.
NICNAS
HUMAN HEALTH IMPLICATIONS
7.1.
7.1.1.
Exposure Assessment
Occupational Exposure
CATEGORY OF WORKERS
Category of Worker
Reformulation – Process operators
Reformulation – packaging line
Reformulation – quality control
Transport workers
Warehouse staff
Retail staff
Exposure Duration
(hours/day)
2–4
4–8
2–4
2–4
2–4
1–2
Exposure Frequency
(days/year)
200
200
200
240
240
365
EXPOSURE DETAILS
Transport and storage
Transport and storage workers may come in contact with the notified polymer in its pure form or as component
of formulated product at a concentration ranging from 30% to > 99% only in the event of accidental rupture of
containers.
Reformulation
During reformulation, dermal, ocular and perhaps inhalation exposure of workers to the notified polymer (at up
to 99% concentration) may occur during weighing and transfer stages, blending, quality control analysis and
cleaning and maintenance of equipment. The notifier states that the exposure is expected to be minimised
through the use of enclosed and automated process and PPE such as overalls, goggles, impervious gloves and
use of self-contained breathing apparatus where the ventilation is inadequate.
Retail workers
Retail workers may come in contact with the notified polymer at a concentration of up to 0.5% in an event of
spill and accidental rupture of containers. The exposure will be mainly dermal though ocular and inhalation may
also be possible. The notifier anticipates that the exposure will be minimised by the use appropriate PPE
including gloves and protective clothing during clean-up of any spills.
End use
Exposure to the notified chemical (at ≤ 0.5% concentration) in laundry detergents may occur in the cleaning
industry. Such professionals may use some PPE to minimise repeated exposure, and good hygiene practices are
expected to be in place. If PPE is used, exposure of such workers is expected to be of a similar or lesser extent
than that experienced by consumers using products containing the notified chemical.
7.1.2. Public Exposure
There will be widespread and repeated exposure of the public to the notified polymer (at up to 0.5%
concentration) through the use laundry detergents. The principal routes of exposure will be dermal, while
accidental ocular exposure is also possible during spills and splashes of liquid laundry detergents and inhalation
exposure may be possible when using laundry detergent in powder form. It is expected that any spilt material
will be washed from the skin.
In addition, household consumers carrying out laundry hand washing have potential for dermal and accidental
ocular exposure to the diluted detergent containing the notified polymer at up to 0.5%. The public may also
come into incidental contact with wash water containing the laundry detergent at low dilutions.
Significant exposure to the notified polymer from residual remains in washed clothes/linen is not expected to
occur as the notified polymer is further diluted in the wash and is expected to be rinsed off from the washed
articles prior to drying.
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September 2014
7.2.
NICNAS
Human Health Effects Assessment
The results from toxicological investigations conducted on lower molecular weight version of the notified
polymer are summarised in the following table. For full details of the studies, refer to Appendix B.
Endpoint
Result and Assessment Conclusion
Rat, acute oral toxicity
LD50 > 2,000 mg/kg bw; low toxicity
Rabbit, skin irritation
irritating
Mutagenicity – bacterial reverse mutation
non mutagenic
Toxicokinetics, metabolism and distribution.
There was no information submitted on the toxicokinetics, metabolism and distribution of the notified polymer.
Based on the high molecular weight (> 10,000 Da) the notified polymer is not expected to be absorbed across
biological membranes (ECHA, 2012).
Acute toxicity.
An acute oral toxicity study in rats was provided for a lower molecular weight analogue of the notified polymer.
An LD50 of > 2,000 mg/kg body weight was established based on no mortality seen at a dose of 2,000 mg/kg
body weight.
Irritation and sensitisation.
A lower molecular weight analogue of the notified polymer was found to be a skin irritant when applied
dermally to rabbits.
Mutagenicity.
A lower molecular weight analogue of the notified polymer was found to be non mutagenic in a bacterial reverse
mutation study.
Health hazard classification
Based on the available information, the notified polymer is recommended for hazard classification according to
the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for
industrial chemicals in Australia. The recommended hazard classification is presented in the following table.
Hazard classification
Hazard statement
Skin Irritation – Category 2
H315 – Causes skin irritation
Based on the available information, the notified polymer is recommended for hazard classification according to
the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004), with the following risk phrase(s):
R38: Irritating to skin.
7.3.
Human Health Risk Characterisation
7.3.1. Occupational Health and Safety
The notified polymer is a skin irritant, however, no systemic toxicity is expected based on the high molecular
weight of the notified polymer making it unlikely to be absorbed across biological membranes. There is
potential for dermal and ocular exposure of workers to the notified polymer (at up to 99% concentration) during
reformulation processes. Exposure should be minimised through the stated use of enclosed, automated
processes, local exhaust ventilation and PPE. Commercial laundry workers may be exposed to products
containing the notified polymer (at ≤ 0.5% concentration). These workers may use PPE to lower exposure. The
risk of irritant effects from the notified polymer at these concentrations is considered to be low, even in the
absence of PPE.
Overall, the risk to workers from exposure to the notified polymer is not considered to be unreasonable, given
the toxicological profile of the notified polymer and the expected use of engineering controls and PPE.
7.3.2. Public Health
The public may have dermal or ocular exposure to the notified chemical (at ≤ 0.5% concentration) through the
use of laundry detergents. The risk of irritant effects from the notified chemical at these concentrations is
considered to be low, even in the absence of PPE.
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NICNAS
Overall, the risk to public health associated with the proposed use of the notified chemical in detergents and
general cleaning products is not considered to be unreasonable.
8.
ENVIRONMENTAL IMPLICATIONS
8.1.
Environmental Exposure & Fate Assessment
8.1.1.
Environmental Exposure
RELEASE OF CHEMICAL AT SITE
The notified polymer will be imported into Australia as a component of a liquid product (up to 30% active), or as
a granulated product (up to 100% active) for reformulation processing, or as a component of finished laundry
detergent products at a level up to 0.5%.
Products containing the notified polymer will be blended locally to prepare laundry detergent products. The
blending and packing processes will occur in semi-automatic and enclosed systems. Release of the notified
polymer to the environment from accidental splashes, drips and spills during these processes is not expected to
be significant. It is estimated that up to 3% of the imported notified polymer may be released to reformulation
sites’ effluent systems from the rinsing of blend vessels and filling lines, and residues remaining in empty
containers. The effluent containing the notified polymer is expected to be discharged to a single sewage
treatment plant and be subsequently discharged to the ocean.
RELEASE OF CHEMICAL FROM USE
During use as a component of laundry products, almost the entire volume of the notified polymer is expected to
be released to sewers. Spills are expected to be cleaned up with an appropriate absorbent material, which is
expected to be disposed of to landfill, or spills may be washed to sewers. Residues of the notified polymer in the
empty containers are likely to be rinsed and added into the washing machine or disposed of to landfill with the
empty containers.
RELEASE OF CHEMICAL FROM DISPOSAL
Small amounts of the notified polymer (up to 1% of the import volume) may remain as residues in empty
containers, which are expected to be disposed of to landfill along with the empty containers.
8.1.2.
Environmental Fate
The notified polymer is not readily biodegradable according to the provided test report. For the details of the
environmental fate studies please refer to Appendix C. It is not expected to have potential for bioaccumulation in
aquatic organisms given the high molecular weight (>1000 Da).
The majority of the notified polymer is expected to be released to sewage treatment plants (STPs) via domestic
wastewater. A small amount of the notified polymer may be sent to landfill as residues in containers or collected
wastes from reformulation. Given the high molecular weight of > 1000 Da and the presence of potential cationic
functional groups, 90% of the notified polymer released to sewage is expected to be removed from the STP
influent (Boethling and Nabholz, 1997) by adsorption to sludge. The sludge containing the notified polymer may
be sent to landfill or applied to soils for land remediation. The Notified polymer released to surface waters is
expected to partition to suspended soils and organic matter. In water or soil, the notified polymer is expected to
ultimately degrade via biotic and/or abiotic processes into water and oxides of carbon and nitrogen.
8.1.3.
Predicted Environmental Concentration (PEC)
The Predicted Environmental Concentration (PEC) has been calculated assuming 100% release of the notified
polymer nationwide to sewage which is for the worst case scenario. It is also assumed that 90% of the notified
polymer will be removed from the STP processes via adsorption to sludge sediment.
Predicted Environmental Concentration (PEC) for the Aquatic Compartment
Total Annual Import/Manufactured Volume
20,000 kg/year
Proportion expected to be released to sewer
100%
Annual quantity of chemical released to sewer
20,000 kg/year
Days per year where release occurs
365 days/year
Daily chemical release:
54.79 kg/day
Water use
200 L/person/day
Population of Australia (Millions)
22.613 million
Removal within STP
90% Mitigation
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Daily effluent production:
Dilution Factor - River
Dilution Factor - Ocean
PEC - River:
PEC - Ocean:
4,523
1.0
10.0
1.21
0.12
ML
μg/L
μg/L
Partitioning to biosolids in STPs Australia-wide may result in an average biosolids concentration of
109 mg/kg (dry wt). Biosolids are applied to agricultural soils, with an assumed average rate of 10 t/ha/year.
Assuming a soil bulk density of 1500 kg/m3 and a soil-mixing zone of 10 cm, the concentration of the notified
chemical may approximate 0.73 mg/kg in applied soil. This assumes that degradation of the notified chemical
occurs in the soil within 1 year from application. Assuming accumulation of the notified chemical in soil for 5
and 10 years under repeated biosolids application, the concentration of notified chemical in the applied soil in
5 and 10 years may approximate 3.6 mg/kg and 7.3 mg/kg, respectively.
STP effluent re-use for irrigation occurs throughout Australia. The agricultural irrigation application rate is
assumed to be 1000 L/m2/year (10 ML/ha/year). The notified chemical in this volume is assumed to infiltrate
and accumulate in the top 10 cm of soil (density 1500 kg/m3). Using these assumptions, irrigation with a
concentration of 1.2 µg/L may potentially result in a soil concentration of approximately 8.1 µg/kg.
Assuming accumulation of the notified chemical in soil for 5 and 10 years under repeated irrigation, the
concentration of notified chemical in the applied soil in 5 and 10 years may be approximately 40.4 µg/kg and
80.8 µg/kg, respectively.
8.2.
Environmental Effects Assessment
The results from ecotoxicological investigations conducted on a lower molecular weight analogue of the
notified polymer are summarised in the table below. Details of these studies can be found in Appendix C.
Endpoint
Fish Toxicity*
Daphnia Toxicity*
Algal Toxicity*
Result
Assessment Conclusion
96 h EC50 > 9400 mg/L
Not harmful to fish
48 h EC50 > 100 mg/L
Not harmful to Daphnia
72 h ErC50 > 100 mg/L
Not harmful to alga
NOEC = 100 mg/L
*Studies conducted on a lower molecular weight analogue of the notified polymer.
The notified polymer is considered to be not harmful to aquatic organisms based on the above endpoints. It is not
formally classified under the Globally Harmonised System of Classification and Labelling of Chemicals (GHS;
United Nations, 2009) for acute and chronic effects to aquatic life.
8.2.1.
Predicted No-Effect Concentration
The Predicted No-Effect Concentration (PNEC) was calculated based on the EC50 > 100 mg/L of an analogue
polymer for Daphnia and alga. A safety factor of 100 was used since endpoints for three trophic levels were
available.
Predicted No-Effect Concentration (PNEC) for the Aquatic Compartment
EC50 (Daphnia and alga)
Assessment Factor
PNEC:
8.3.
> 100
100
> 1000
mg/L
μg/L
Environmental Risk Assessment
Risk Assessment
Q - River
Q - Ocean
PEC μg/L
1.21
0.12
PNEC μg/L
>1000
> 1000
Q
< 0.001
0.0
The Risk Quotients (Q = /PNEC) have been calculated to be < 0.1 for river water and ocean water
compartments. This suggests an acceptable risk to the aquatic environment from the proposed use of the notified
polymer.
On the basis of the PEC/PNEC ratio and the assessed use pattern, the notified polymer is not expected to pose an
unreasonable risk to the environment.
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APPENDIX A: PHYSICAL AND CHEMICAL PROPERTIES
Glass Transition Temperature
Method
Remarks
Test Facility
OECD TG 102 Melting Point/Melting Range.
No melting temperature was observed between -50 °C and the vaporization of the test
substance. A reproducible glass transition was observed.
BASF (2008)
Density
Method
Remarks
Test Facility
1,124 kg/m3 at 20 °C
OECD TG 109 Density of Liquids and Solids.
Duplicate measurements using Pycnometer method.
BASF (2008)
≥ 686 g/L at 23 °C
Water Solubility
Method
Remarks
Test Facility
OECD TG 105 Water Solubility.
EC Council Regulation No 440/2008 A.6 Water Solubility.
Flask Method was used. A series of mixtures of notified polymer/water were prepared at
deferent ratios and stirred for 3 day at 23 °C. The water solubility was determined to be
68.6-79.7 g notified polymer/100 g mixture by visually judgement of the mixtures. The
solubility is expected to be ≥ 686 g/L assuming a density of 1000 g/L for the mixtures.
BASF (2009)
Hydrolysis as a Function of pH
Method
Remarks
Test Facility
Test Facility
t1/2 > 1 year at 25 °C
OECD TG 111 Hydrolysis as a Function of pH
The hydrolytic stability was investigated by measuring 1H-NMR. No hydrolysis was
observed within 5 days at 50 °C and pH of 4, 7, and 9. Therefore, the t 1/2 is expected to be
>1 year at 25°C. The notified polymer is considered to be hydrolytically stable.
BASF (2009)
Partition Coefficient (noctanol/water)
Method
Remarks
176 °C
log Pow ≤ - 4.8 at 23 °C
Estimated from the single solubilities in octanol and in water
The solubility in octanol was determined to be < 10 mg/L at 23 °C. The P OW is therefore
estimated to be ≤ 1.46 × 10-5 (< 10 (mg/L)/≥ 686,000 mg/L), which is equivalent to log P OW
≤ - 4.8.
BASF (2009)
Particle Size
Method
Remarks
Test Facility
ISO13320-1 Laser Diffraction Method.
The notified polymer had a particle size between 120 and 2187 µm. There was no material
in the test sample determined to have a particle size < 100 µm.
BASF (2008)
PUBLIC REPORT: LTD/1777
Page 13 of 19
September 2014
NICNAS
APPENDIX B: TOXICOLOGICAL INVESTIGATIONS
B.1.
Acute toxicity – oral
TEST SUBSTANCE
A lower molecular weight analogue of the notified polymer
METHOD
Species/Strain
Vehicle
Remarks - Method
OECD TG 401 Acute Oral Toxicity.
Rat/Wistar/ CHBB: THOM (SPF)
Distilled water
No significant deviation from the OECD protocol.
RESULTS
Group
Number and Sex
of Animals
5M&5F
1
LD50
Signs of Toxicity
Dose
mg/kg bw
2,000
Mortality
0
> 2,000 mg/kg bw
One day after the administration of the test substance, signs of toxicity
were observed in male and female rats. Two of the male rats showed
impaired general state, dyspnoea, staggering and piloerection and one
female rat showed impaired general state, dyspnoea and piloerection. It
was not mentioned as to whether the symptoms were seen in the same rat
or different rats or when the symptoms resolved. The weight gains
measured on the treatment day, day 7 and 14 showed no adverse effect of
the test substance on the weight gain.
None
The LD50 was derived based on an absence of mortality during the test.
Effects in Organs
Remarks - Results
CONCLUSION
The test substance is of low toxicity via the oral route.
TEST FACILITY
BASF (1994a)
B.2.
Irritation – skin
TEST SUBSTANCE
A lower molecular weight analogue of the notified polymer
METHOD
Species/Strain
Number of Animals
Vehicle
Observation Period
Type of Dressing
Remarks - Method
OECD TG 404 Acute Dermal Irritation/Corrosion.
Rabbit/White Vienna
3 (1 male and 2 females)
Distilled water
8 days
Semi-occlusive.
No significant deviations from the OECD protocol.
RESULTS
Lesion
Mean Score*
Animal No.
Maximum
Value
Maximum
Duration of Any
Effect
1
2
3
Erythema/Eschar
2.00 2.66 2.33
3
< 8 days
Oedema
0.33 1.66 0.33
3
< 8 days
* Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Remarks - Results
CONCLUSION
PUBLIC REPORT: LTD/1777
Maximum Value at End
of Observation Period
0
0
All three of the test animals showed scaling on the skin at the day 8
observation.
The test substance is irritating to the skin.
Page 14 of 19
September 2014
TEST FACILITY
B.3.
NICNAS
BASF (1994b)
Genotoxicity – bacteria
TEST SUBSTANCE
A lower molecular weight analogue of the notified polymer
METHOD
OECD TG 471 Bacterial Reverse Mutation Test.
Plate incorporation procedure and Pre incubation procedure
S. typhimurium: TA1535, TA1537, TA98 & TA100
S9 fraction from Aroclor 1254 induced rat liver
a) With metabolic activation:
20, 100, 500, 2,500 and 5,000 µg/plate
b) Without metabolic activation: 20, 100, 500, 2,500 and 5,000 µg/plate
Distilled water
No significant deviations from the OECD protocol.
Vehicle and positive controls were used in parallel with the test substance.
Positive control: i) without S9: N-methyl-N’-nitro-N-nitrosoguanidine
(TA100 and TA1535), 4-Nitro-o-phenylendiamine (TA98) & 9Aminoacridine (TA1537); ii) with S9: 2-Aminoanthracene (TA98, TA100,
TA1535 and TA1537).
Species/Strain
Metabolic Activation System
Concentration Range in
Main Test
Vehicle
Remarks - Method
RESULTS
Metabolic Activation
Absent
Test 1 (Plate incorporation)
Test 2 (Pre incubation)
Present
Test 1 (Plate incorporation)
Test 2 (Pre incubation)
Remarks - Results
Test Substance Concentration (µg/plate) Resulting in:
Cytotoxicity in
Precipitation
Genotoxic Effect
Main Test
> 5,000
≥ 2,500
> 5,000
> 5,000
Negative
Negative
> 5,000
≥ 2,500
> 5,000
> 5,000
Negative
Negative
There was no significant change in the number of revertant colonies
observed with any of the test substance concentrations when compared to
vehicle control.
The positive controls gave satisfactory responses confirming the validity
of the test system.
CONCLUSION
The test substance was not mutagenic to bacteria under the conditions of
the test.
TEST FACILITY
BASF (1994c)
PUBLIC REPORT: LTD/1777
Page 15 of 19
September 2014
NICNAS
APPENDIX C: ENVIRONMENTAL FATE AND ECOTOXICOLOGICAL INVESTIGATIONS
C.1.
Environmental Fate
C.1.1. Ready biodegradability
TEST SUBSTANCE
A lower molecular weight analogue of the notified polymer
METHOD
OECD TG 301 B Ready Biodegradability: CO2 Evolution Test (Modified
Sturm Test)
Activated sludge
29 days
Not applied
The amount of CO2 at the end of the test was compared with the calculated
theoretical CO2-production (ThCO2) for expression of the degradation
degree
The study followed the above test guideline and good laboratory practice
(GLP) principles. The test was conducted in duplicate at a concentration of
38.5 mg/L approximates to 20.0 mg/L DOC. Tests of blank control
(duplicate), reference control and toxicity control were also conducted.
Inoculum
Exposure Period
Auxiliary Solvent
Analytical Monitoring
Remarks - Method
RESULTS
Day
3
29
Test substance
% Degradation
2
7
Remarks - Results
Day
7
29
Sodium benzoate
% Degradation
70
97
All the test validity criteria were met. The toxicity control reached 54%
degradation by 29 day, indicating the test substance is not toxic to the
micro-organisms. The test results in the table above indicate that the test
substance is not readily biodegradable. The test substance is considered to
be an acceptable analogue of the notified polymer. Therefore, the notified
polymer is not expected to be aerobically readily biodegradable.
CONCLUSION
The test substance and, by inference, the notified polymer are not readily
biodegradable
TEST FACILITY
BASF (1994d)
C.2.
Ecotoxicological Investigations
C.2.1. Acute toxicity to fish
TEST SUBSTANCE
A lower molecular weight analogue of the notified polymer
METHOD
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
OECD TG 203 Fish, Acute Toxicity Test –Static Test
Zebra fish
96 hours
None
250 mg CaCO3/L
The test concentrations were measured using a pyrolysis gas
chromatograph
The study followed the above test guideline and good laboratory practice
(GLP) principles. Based on the outcome of two range-finding tests, the
definitive test was conducted at four test concentrations up to 10,000 mg/L
(nominal).
Remarks – Method
RESULTS
PUBLIC REPORT: LTD/1777
Page 16 of 19
September 2014
NICNAS
Concentration mg/L
Nominal
Actual (96 h)
Control
0
50
38
100
99.3
5,000
4980
10,000
9400
LC50
NOEC
Remarks – Results
Number of Fish
10
10
10
10
10
1h
0
0
0
0
0
24 h
0
0
0
0
0
Mortality
48 h 72 h
0
0
0
0
0
0
0
0
0
0
96 h
0
0
0
0
0
> 9,400 mg/L at 96 hours (measured)
9,400 mg/L at 96 hours (measured)
All the test validity criteria were met. No mortality or sublethal effects
were observed at all test levels. The test substance is not expected to be
harmful to fish based on the test outcome.
The test substance is considered to be an acceptable analogue of the
notified polymer. Therefore, the notified polymer is not expected to be
harmful to fish.
CONCLUSION
The test substance and, by inference, the notified polymer are not harmful
to fish
TEST FACILITY
BASF (1994e)
C.2.2. Acute toxicity to aquatic invertebrates
TEST SUBSTANCE
A lower molecular weight analogue of the notified polymer
METHOD
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks - Method
OECD TG 202 Daphnia sp. Acute Immobilisation Test – Static Test
Daphnia magna
48 hours
None
2.44 mmol CaCO3/L
The details regarding test concentrations analysis were not provided
The study followed the above test guideline and good laboratory practice
(GLP) principles. The test was conducted at four concentrations ranging
from 100 to 12.5 mg/L with a dilution factor of 2.
RESULTS
Concentration mg/L
Nominal
Control
12.5
25
50
100
Number of D. magna
LC50
NOEC
Remarks - Results
> 100 mg/L at 48 hours (nominal)
100 mg/L at 48 hours (nominal)
All the test validity criteria were met. The test concentrations at 48 hour
were indicated to be in the range of 94.8%-115.5% of the nominal
concentrations. No details were provided. The endpoints are presented
based on nominal concentrations.
No dose response effects were observed at all the test levels. The test
substance is not expected to be harmful to Daphnia based on the test
results.
The test substance is considered to be an acceptable analogue of the
notified polymer. Therefore, the notified polymer is not expected to be
harmful to Daphnia.
CONCLUSION
PUBLIC REPORT: LTD/1777
20
20
20
20
20
Number Immobilised
24 h
48 h
0
0
0
0
0
1
0
0
0
0
The test substance and, by inference, the notified polymer, are not harmful
Page 17 of 19
September 2014
NICNAS
to Daphnia
TEST FACILITY
BASF (1994f)
C.2.3. Algal growth inhibition test
TEST SUBSTANCE
A lower molecular weight analogue of the notified polymer
METHOD
Species
Exposure Period
Concentration Range
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks - Method
OECD TG 201 Alga, Growth Inhibition Test
72 hours
Nominal:
0.39, 0.78, 1.56, 3.13, 6.25, 12.5, 25, 50, 100 mg/L
None
Not reported
The details regarding test concentrations analysis were not provided
The study followed the above test guideline and good laboratory practice
(GLP) principles.
RESULTS
Biomass
EbC50
mg/L at 72 h
> 100
Remarks - Results
Growth
NOEC
mg/L
3.13
ErC50
mg/L at 72 h
> 100
NOEC
mg/L
100
All the test validity criteria were met. The test concentrations at 72 hour
were indicated recoveries of 80% - 105%. No details were provided. The
endpoints are presented based on nominal concentrations.
No significant inhibitory effects were observed at all test levels. An
inhibition of 13.1% based on biomass was observed at the concentration of
6.25 mg/L, and an inhibition of 7.1% based on growth rate was observed
at the top test level of 100 mg/L. The test substance is not expected to be
harmful to alga based on the test results.
The test substance is considered to be an acceptable analogue of the
notified polymer. Therefore, the notified polymer is not expected to be
harmful to alga.
CONCLUSION
The test substance and, by inference, the notified polymer are not harmful
to alga
TEST FACILITY
BASF (1994g)
PUBLIC REPORT: LTD/1777
Page 18 of 19
September 2014
NICNAS
BIBLIOGRAPHY
BASF (1994a) [Analogue data] Study on the Acute Oral Toxicity of Sokalan PG 55 X Pulver in Rats (Project
No. 10A0137/941034, June, 1994). Ludwigshafen/Rhein, Germany. BASF Aktiengesellschaft, Department
of Toxicology (Unpublished report submitted by the notifier).
BASF (1994b) [Analogue data] Study on the Acute Dermal Irritation/Corrosion of Sokalan PG 55 X Pulver in
The Rabbit (Project No. 18H0137/942052, June, 1994). Ludwigshafen/Rhein, Germany. BASF
Aktiengesellschaft, Department of Toxicology (Unpublished report submitted by the notifier).
BASF (1994c) [Analogue data] Report on The Study of Sokalan PG 55 X Pulver in The Ames Test (Project No.
40M0137/944094, July, 1994). Ludwigshafen/Rhein, Germany. BASF Aktiengesellschaft, Department of
Toxicology (Unpublished report submitted by the notifier).
BASF (1994d) [Analogue data] Determination of the Biodegradability of Sokalan PG 55 X Powder in the CO 2Evolution-Test (modified Sturm-Test) (Project No. 94/0527/22/1, June, 1994). Ludwigshafen, GE, BASF
Aktiengesellschaft (Unpublished report submitted by the notifier).
BASF (1994e) [Analogue data] Acute Toxicity Study on the Zebra Fish (Brachydanio rerio HAM. and BUCH.)
of Sokalan PG 55 X Pulver in a Static System (96 hours) (Project No. 17F0137/945018, July, 1994).
Ludwigshafen, GE, BASF Aktiengesellschaft (Unpublished report submitted by the notifier).
BASF (1994f) [Analogue data] Determination of Acute Toxicity of Sokalan PG 55 X Pulver to the Water Flea
Daphnia magna Straus (Project No. 94/0527/50/1, July, 1994). Ludwigshafen, GE, BASF Aktiengesellschaft
(Unpublished report submitted by the notifier).
BASF (1994g) [Analogue data] Determination of Acute Toxicity of the Inhibitory Effect of Sokalan PG 55 X
Pulver on Cell Division of the Green Alga Scenedesmus subspicatus (Project No. 94/0527/60/1, July, 1994).
Ludwigshafen, GE, BASF Aktiengesellschaft (Unpublished report submitted by the notifier).
BASF (2008) [Notified chemical] Physico-chemical properties of Sokalan HP 56 granules (Study No.
08L00250, January 2008). Ludwigshafwen/Rhein, Germany. GKA Competence Centre Analytics, BASF SE
(Unpublished report submitted by the notifier).
BASF (2009) [Notified chemical] Final Report Physico-chemical properties of “Sokalan HP 56 Granules”
(Study No. 08L00250, May, 2009). Ludwigshafen, GE, BASF Aktiengesellschaft (Unpublished report
submitted by the notifier).
Boethling, R.S. and Nabholz V.J. (1997). Environmental Assessment of polymers under the U.S. Toxic
Substances Control Act, pp. 187-234, in Ecological Assessment of Polymers Strategies for Product
Stewardship and Regulatory Programs, Hamilton, J.D. and R. Sutcliffe (eds.).
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specific
guidance,
November
2012,
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1.1.
European
Chemicals
Agency
<http://echa.europa.eu/documents/10162/13632/information_requirements_r7c_en.pdf>. Accessed 15 July
2015.
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PUBLIC REPORT: LTD/1777
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